Pharmaceutical Compositions for Treating Thermal Injuries and Wounds Combined with Bone Injuries

ABSTRACT

The present invention relates to a pharmaceutical composition for treating thermal injuries and wounds combined with bone injuries. More specifically, the present invention relates to a pharmaceutical composition for treating thermal injuries and wounds combined with bone injuries characterized in consisting of 4%-12% beeswax and 88%-96% sesame oil extract containing such raw materials as  Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris  and  Lumbricus  by weight based on the total weight of the said composition, wherein the content of  Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris  or  Lumbricus  based on their dry weight is respectively 1%-6% of the total weight of the sesame oil. The pharmaceutical composition of the present invention can treat thermal injuries involving human skin, subcutaneous tissues and bones, as well as involving bone wounds, especially open fractures, deep thermal injuries combined with bone injuries, and deep thermal injuries combined with bone necrosis caused by trauma, such as deep burns combined with bone injuries or bone necrosis.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/763,126, which is a U.S. nationalization of PCT ApplicationNo. PCT/CN2013/076412, filed May 29, 2013, which claims the prioritybenefit of Chinese Patent Application Serial No. CN201310027487.8, filedJan. 24, 2013, the text and drawings of all of which are herebyincorporated by reference in their entireties.

FIELD OF THE INVENTION

The present invention relates to a pharmaceutical composition,specifically, to a botanical pharmaceutical composition for thetreatment of thermal injury and wounds complicated by bone injury.

BACKGROUND OF THE INVENTION

The inventor of the present invention disclosed a pharmaceuticalcomposition for the treatment of thermal injury of warm-blooded animalsor human beings in his Chinese Patent Application No. 93100276.1,characterized in that said composition by consisting of 3%-15% ofbeeswax and 85%-97% of sesame oil extract containing such raw materialsas Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus by weight based on the total weightof the said composition, of which the content of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris orLumbricus based on their dry weight is respectively 2%-10% of the totalweight of the sesame oil.

The said thermal injury (thermal damage) refers to the degeneration andnecrosis injuries of cells and tissues of mammal including human causedby temperature changes, such as scalds, burns, low-temperature skindamage, cold injury, electrical injury, chemical solution or radiationinduced injuries and the like. The affected human tissues vary with theseverities of thermal injuries or wounds and ulcers, with epidermis,dermis, subcutaneous tissue, muscle, and bone involved successively.

Bone injury of human includes shin bone injury and cartilage injury.

It is well known for the person skilled in the art that thermal injuryor wounds of different causes may commonly be complicated by bone injuryin clinical practices, such as deep burn injury often involves thedegeneration and necrosis of bone. In the prior art, especially ChinesePatent Application No. 93100276.1 disclosed a pharmaceutical compositionfor the treatment of thermal injury of warm-blooded mammal or humanbeings, wherein the said composition can only be used for treatingtraumatic wounds deep to periosteum. However, after the painstakingresearch, the present inventor develops a new optimized formula based onthe formula above which is both effective for the treatment of thermalinjury of human skin, subcutaneous tissues and bones as well as woundsand ulcers involving bones, especially effective for the treatment ofopen injury caused by traumas, deep thermal injury complicated by boneinjury and deep thermal injury complicated by osteonecrosis, such asdeep burns complicated with bone injury or osteonecrosis. Thepharmaceutical composition according to the present invention is animprovement of Chinese Patent Application No. 93100276.1.

SUMMARY OF THE INVENTION

The object of the present invention is thus to provide a botanicalpharmaceutical composition for the treatment of thermal injury andwounds complicated with bone injury.

Thus, the first aspect of the present invention involves apharmaceutical composition for the treatment of thermal injury andwounds complicated with bone injury, characterized in that saidpharmaceutical composition consists of 4%-12% of beeswax and 88%-96% ofsesame oil extract containing such raw materials as Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris andLumbricus by weight based on the total weight of said composition, ofwhich the content of Radix Scutellariae, Coptis Chinensis, CortexPhellodendri, Pericarpium Papaveris or Lumbricus based on their dryweight is respectively 1%-6% of the total weight of the sesame oil.

Preferably, the content of Radix Scutellariae, Coptis Chinensis, CortexPhellodendri, Pericarpium Papaveris, or Lumbricus based on their dryweight is respectively 2%-4% of the total weight of the sesame oil.

More preferably, the content of Radix Scutellariae, Coptis Chinensis,Cortex Phellodendri, Pericarpium Papaveris or Lumbricus based on theirdry weight is respectively 3% of the total weight of the sesame oil.

Most preferably, the said composition consists of:

1) 4% of beeswax and 96% of sesame oil extract containing such rawmaterials as Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus by weight based on the total weightof said composition, wherein the content of Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris or Lumbricus basedon their dry weight is respectively 6% of the total weight of the sesameoil;

2) 6% of beeswax and 94% of sesame oil extract containing such rawmaterials as Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus by weight based on the total weightof said composition, wherein the content of Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris or Lumbricus basedon their dry weight is respectively 3% of the total weight of the sesameoil;

3) 8% of beeswax and 92% of sesame oil extract containing such rawmaterials as Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus by weight based on the total weightof said composition, wherein the content of Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris or Lumbricus basedon their dry weight is respectively 1% of the total weight of the sesameoil;

4) 8% of beeswax and 92% of sesame oil extract containing such rawmaterials as Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus by weight based on the total weightof said composition, wherein the content of Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris and Lumbricusbased on their dry weight is respectively 5.5%, 5.5%, 5.5%, 2.2% and2.2% of the total weight of the sesame oil;

5) 10% of beeswax and 90% of sesame oil extract containing such rawmaterials as Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus by weight based on the total weightof said composition, wherein the content of Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris and Lumbricusbased on their dry weight is respectively 2% of the total weight of thesesame oil;

6) 12% of beeswax and 88% of sesame oil extract containing such rawmaterials as Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus by weight based on the total weightof said composition, wherein the content of Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris and Lumbricusbased on their dry weight is respectively 1% of the total weight of thesesame oil;

Preferably, the said bone injury refers to open traumatic injurycomplicated by fracture, deep thermal injury with bone injury orosteonecrosis.

More preferably, the said bone injury refers to bone injury combinedwith periosteum damage.

In the second aspect of the present invention, it involves the use ofthe pharmaceutical composition in the preparation of medicaments for thetreatment of thermal injury complicated by bone injury, wherein saidcomposition consists of 4%-12% of beeswax and 88%-96% of sesame oilextract containing such raw materials as Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris and Lumbricus byweight based on the total weight of the said composition, of which thecontent of Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris or Lumbricus based on their dry weight isrespectively 1%-6% of the total weight of the sesame oil.

Preferably, the content of Radix Scutellariae, Coptis Chinensis, CortexPhellodendri, Pericarpium Papaveris, or Lumbricus based on their dryweight is respectively 2%-4% of the total weight of the sesame oil.

More preferably, the content of Radix Scutellariae, Coptis Chinensis,Cortex Phellodendri, Pericarpium Papaveris, or Lumbricus based on theirdry weight is respectively 3% of the total weight of the sesame oil.

Preferably, the said bone injury refers to open traumatic injurycomplicated by fracture, deep thermal injury with bone injury orosteonecrosis.

More preferably, the said bone injury refers to bone injury combinedwith periosteum damage.

In the third aspect of the present invention, it involves apharmaceutical composition consisting of 4%-12% of beeswax and 88%-96%of sesame oil extract containing such raw materials as RadixScutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris and Lumbricus by weight based on the total weight of the saidcomposition, of which the content of Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris and Lumbricusbased on their dry weights is 1%-6% of the total weight of the sesameoil, and said composition is used for the treatment of thermal injurycomplicated by bone injury.

Preferably, the said thermal injury refers to open traumatic injurycomplicated by fracture, deep thermal injury with bone injury orosteonecrosis.

In the fourth aspect of the present invention, it involves a method oftreating open traumatic injury complicated by fracture, deep thermalinjury with bone injury and osteonecrosis, comprising administration ofeffective dose of pharmaceutical composition to the patient, whereinsaid composition consists of 4%-12% of beeswax and 88%-96% of sesame oilextract containing such raw materials as Radix Scutellariae, CoptisChinensis, Cortex Phellodendri, Pericarpium Papaveris and Lumbricus byweight based on the total weight of the said composition, of which thecontent of Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris or Lumbricus based on their dry weight isrespectively 1%-6% of the total weight of the sesame oil.

In other words, based on the prior art, the present inventor madeappropriate adjustment to the proportions of the raw materials, whichproduced unexpected technical effect on the treatment of thermal injurycomplicated by bone injury and simple bone injury such as open fracture.Especially, the inventor found that when the contents of RadixScutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris and Lumbricus are beyond the range of 1%-6% by dry weightbased on the total weight of the sesame oil respectively, there are notherapeutic effects on bone injury, while when their contents are withinthe range of 1%-6% respectively, the composition can bring significanttherapeutic effects on bone injury. More especially, when the contentsof these raw materials are 2%-4%, particularly 3%, by dry weight basedon the total weight of the sesame oil respectively, the therapeuticeffects of the composition are much better.

The said bone injury in the present invention includes open traumaticinjury complicated by bone fracture, deep thermal injury with boneinjury and osteonecrosis. Particularly the said bone injury refers tobone injury with periosteum damage. For instance, for the open traumaticinjury complicated by bone injury, such as the open bone fracturecommonly seen in a catastrophe (e.g. earthquake), if not treated timely,it may often result in amputation and lifelong disability of victims asit is susceptible to infection due to serious wound contamination.Therefore, the present invention is to provide a pharmaceuticalcomposition that can be applied in treating open bone fracture directly,and thus also provide a pharmaceutical composition of treating boneinjury, characterized in that said composition consists of 4%-12% ofbeeswax and 88%-96% of sesame oil extract containing such raw materialsas Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus by weight based on the total weightof the said composition, of which the contents of these raw materialsbased on their dry weights are 1%-6% of the total weight of the sesameoil respectively.

The present invention also provides a method of treating open traumaticinjury complicated by bone fracture, deep thermal injury with boneinjury and osteonecrosis, comprising administration of an effective doseof the pharmaceutical composition onto the affected locations, whereinthe said pharmaceutical composition consists of 4%-12% of beeswax and88%-96% of sesame oil extract containing such raw materials as RadixScutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris and Lumbricus by weight based on the total weight of the saidcomposition, of which the contents of these raw materials based on theirdry weights are 1%-6% of the total weight of the sesame oilrespectively. Preferably, the contents of these raw materials based ontheir dry weights are 2%-4% of the total weight of the sesame oilrespectively.

In addition, the invention also provides the use of a pharmaceuticalcomposition in the preparation of medicaments for the treatment of boneinjury, wherein the said composition consists of 4%-12% of beeswax and88%-96% of sesame oil extract containing such raw materials as RadixScutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris and Lumbricus by weight based on the total weight of the saidcomposition, of which the contents of these raw materials based on theirdry weights are 1%-6% of the total weight of the sesame oilrespectively.

A method of treating open traumas complicated by fracture and/or deepthermal injury with bone injury and/or osteonecrosis is disclosed,comprising administration of an effective dose of a pharmaceuticalcomposition onto the affected locations, wherein said pharmaceuticalcomposition comprises 4%-12% of beeswax by weight based on the totalweight of said composition, and 88%-96% of sesame oil extract by weightbased on the total weight of said composition, wherein the sesame oilextract contains one or more components selected from the groupconsisting of Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris, and Lumbricus, and any combination thereof,wherein each of the one or more components based on their dry weight is1%-6% of the total weight of the sesame oil. In some embodiments, eachof the one or more components based on their dry weight is 2%-4% of thetotal weight of the sesame oil. In some embodiments, each of the one ormore components based on their dry weight is 3% of the total weight ofthe sesame oil.

In some embodiments, the pharmaceutical composition comprises 4% ofbeeswax by weight based on the total weight of said composition, and 96%of sesame oil extract by weight based on the total weight of saidcomposition, wherein the sesame oil extract contains one or morecomponents selected from the group consisting of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris, andLumbricus, and any combination thereof, wherein the content of each ofthe one or more components based on their dry weight is 6% of the totalweight of the sesame oil.

In some embodiments, the pharmaceutical composition comprises 6% ofbeeswax by weight based on the total weight of said composition, and 94%of sesame oil extract by weight based on the total weight of saidcomposition, wherein the sesame oil extract contains one or morecomponents selected from the group consisting of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris, andLumbricus, and any combination thereof, wherein the content of each ofthe one or more components based on their dry weight is 3% of the totalweight of the sesame oil.

In some embodiments, the pharmaceutical composition comprises 8% ofbeeswax by weight based on the total weight of said composition, and 92%of sesame oil extract by weight based on the total weight of saidcomposition, wherein the sesame oil extract contains one or morecomponents selected from the group consisting of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris, andLumbricus, and any combination thereof, wherein the content of each ofthe one or more components based on their dry weight is 1% of the totalweight of the sesame oil.

In some embodiments, the pharmaceutical composition comprises 8% ofbeeswax by weight based on the total weight of said composition, and 92%of sesame oil extract by weight based on the total weight of saidcomposition, wherein the sesame oil extract contains 5.5% RadixScutellariae, 5.5% Coptis Chinensis, 5.5% Cortex Phellodendri, 2.2%Pericarpium Papaveris, and 2.2% Lumbricus, each component by weightbased on the total weight of the sesame oil.

In some embodiments, the pharmaceutical composition comprises 10% ofbeeswax by weight based on the total weight of said composition, and 90%of sesame oil extract by weight based on the total weight of saidcomposition, wherein the sesame oil extract contains one or morecomponents selected from the group consisting of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris, andLumbricus, and any combination thereof, wherein the content of each ofthe one or more components based on their dry weight is 2% of the totalweight of the sesame oil.

In some embodiments, the pharmaceutical composition comprises 12% ofbeeswax by weight based on the total weight of said composition, and 88%of sesame oil extract by weight based on the total weight of saidcomposition, wherein the sesame oil extract contains one or morecomponents selected from the group consisting of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris, andLumbricus, and any combination thereof, wherein the content of each ofthe one or more components based on their dry weight is 1% of the totalweight of the sesame oil.

In some embodiments, said bone injury comprises bone injury withperiosteum damage.

In some embodiments, said administration comprises applying thepharmaceutical composition onto the affected locations with a thicknessof about 1-3 mm. In some embodiments, said administration comprisesapplying the pharmaceutical composition onto the affected locations witha thickness of 3 mm.

In some embodiments, the pharmaceutical composition is administered as amultiple dose treatment. In some embodiments, the multiple dosetreatment occurs over a time period of from 7 to 40 days. In someembodiments, the multiple dose treatment occurs over a time period of 7days. In some embodiments, the multiple dose treatment occurs over atime period of 10 days. In some embodiments, the multiple dose treatmentoccurs over a time period of 40 days.

In some embodiments, the open traumas complicated by fracture and/ordeep thermal injury with bone injury and/or osteonecrosis are on awarm-blooded animal. In some embodiments, the open traumas complicatedby fracture and/or deep thermal injury with bone injury and/orosteonecrosis are on a human being. In some embodiments, the bone injuryis selected from shin bone injury, skull bone injury, and/or cartilageinjury.

According to the specific experiments, only the low doses of RadixScutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris, and Lumbricus in the sesame oil extract (1-6% of the totalweight of the sesame oil respectively based on their dry weights) hasthe therapeutic effect on thermal injuries, wounds, and ulcers combinedwith bone injury. In contrast, when the contents of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris, andLumbricus in the sesame oil extract are higher than 6% or lower than 1%,there is no therapeutic effect on thermal injuries and wounds combinedwith bone injuries. According to the analysis of the inventor, thehigher concentration of Radix Scutellariae, Coptis Chinensis, CortexPhellodendri, Pericarpium Papaveris, and Lumbricus may inhibit the cellgrowth of thermal injury and the wounds combined with bone injuries,thus it has no therapeutic effect on thermal injuries and woundscombined with bone injuries. And the lower concentration of RadixScutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris, and Lumbricus in the sesame oil extract does not reach thetherapeutic dosage concentration, which will cause the treatmentfailure.

Regarding to the proportion of Radix Scutellariae, Coptis Chinensis,Cortex Phellodendri, Pericarpium Papaveris, and Lumbricus in the sesameoil extract, it has found that the specific proportion of them has norelevant impact on the treatment result, as long as they occupy 1-6% ofthe total weight of the sesame oil extract respectively based on theirdry weights.

DESCRIPTION OF DRAWINGS

FIG. 1 is the photo of the deep burn (chemical) injury of shank and footcombined with bone injury in experimental example 1.

FIG. 2 is the photo of the application of the present pharmaceuticalcomposition obtained in example 1 on the wounds directly and the removalof necrotic periosteum and tissues 2 days after the application inexperimental example 1.

FIG. 3 is the photo of drilling the holes in the bone in experimentalexample 1.

FIG. 4 is the photo of new skin regenerated from the originalgranulation wound and the new granulation tissues grew out from thedrilled holes in experimental example 1.

FIG. 5 is the photo of the new skin regenerated from the originalgranulation wound and the new granulation tissues grew out from thedrilled holes in experimental example 1.

FIG. 6 is the photo of the new skin regenerated from the bonegranulation tissues in experimental example 1.

FIG. 7 is the photo of the electrical injury of head top combined withosteocranium injury in experimental example 2.

FIG. 8 is the photo of the drilled holes in skull bone after thesurgical debridement of the necrotic tissues in experimental example 2.

FIG. 9 is the photo showing the wound condition after 10 days treatmentin experimental example 2.

FIG. 10 is the photo showing the healing of the damaged tissues inexperimental example 2.

FIG. 11 shows the electron microscope photo of the slices of healed skinin experimental example 2.

FIG. 12 shows the electron microscope photo of the slices of healed skinin experimental example 2.

FIG. 13 shows the open fracture wounds in experimental example 3.

FIG. 14 shows the conditions after the fracture fixation and woundssuture in experimental example 3.

FIG. 15 shows the healed open fracture in experimental example 3.

FIG. 16 shows the defect injury of severe skull bone electrical injuryin experimental example 4.

FIG. 17 shows the defect injury of severe skull bone electrical injuryin experimental example 4.

FIG. 18 shows the wounds after the application of the presentpharmaceutical composition 4 in experimental example 4.

FIG. 19 shows the X-ray image of skull bone in experimental example 4.

FIG. 20 shows the growing conditions of skull skin in experimentalexample 4.

FIG. 21 shows the X-ray image in experimental example 4.

FIG. 22 shows obvious regeneration of bone tissues and the significantlydecreased exposed area of periosteum 40 days after the treatment inexperimental example 4.

FIG. 23 shows the restoration of skull bone, soft tissues, and skin inexperimental example 4.

FIG. 24 shows the growing of head hair after the healing of skull woundsand plastic surgery of head skin in experimental example 4.

FIG. 25 shows the severe burn injury of neck, head, and face inexperimental example 5.

FIG. 26 shows the wound condition after the application of the controldrug C of experimental example 4 in example 5.

FIG. 27 shows the wound conditions after the application of thepharmaceutical composition 5 in example 5.

FIG. 28 shows the wound conditions after the application of thepharmaceutical composition 5 in example 5.

FIG. 29 shows the skin flap grafting in example 5.

FIG. 30 shows the skin flap grafting in example 5.

FIG. 31 shows the skin flap grafting in example 5.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will be described in detail according to theunlimited examples below. It should be understood by the person skilledin the art that many modifications can be made for the present inventionwithout departing from the spirit of the present invention, suchmodifications also fall into the scope of the present invention.

Unless indicated otherwise, the experimental methods in the followingare all conventional methods and all the experimental materials areavailable commercially.

EXAMPLE 1

According to the method disclosed in example 1 of Chinese PatentApplication No. 93100276.1, the raw materials of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Lumbricus and PericarpiumPapaveris were weighed each 6 kg and crushed according to the commonmethod in the art.

100 Kg of sesame oil bought in market was added into the extractionkettle as extract agent and heated to 120° C. Then the raw materialsabove were added into the kettle with hot sesame oil and stirred at 150°C. for 45 min

The extractant was subjected to filtration, removing of the filterresidues and precipitation at room temperature. The supernatant wascollected to obtain 100 Kg of extractant which is the sesame oilcontaining the above raw materials.

96 Kg of the resulted sesame oil containing raw materials above wasmixed with 4 Kg of beeswax from the market according to the commonmethod in the art to afford 100 Kg of pharmaceutical composition 1.

EXAMPLE 2

The pharmaceutical composition was prepared according to the method ofexample 1 except that the composition was consist of 6 Kg of beeswax and94 Kg of sesame oil extract containing 3 kg of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris andLumbricus respectively, and the temperature of sesame oil was kept at160° C. and stirred for 40 min to afford pharmaceutical composition 2.

EXAMPLE 3

The pharmaceutical composition was prepared according to the method ofexample 1 except that the composition was consist of 8 Kg of beeswax and92 Kg of sesame oil extract containing 1 kg of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris andLumbricus respectively, and the temperature of sesame oil was kept at155° C. and stirred for 40 min to afford pharmaceutical composition 3.

EXAMPLE 4

The pharmaceutical composition was prepared according to the method ofexample 1 except that the composition was consist of 8 Kg of beeswax and92 Kg of sesame oil extract containing 5.5 kg of Radix Scutellariae, 5.5kg of Coptis Chinensis, 5.5 kg of Cortex Phellodendri, 2.2 kg ofPericarpium Papaveris and 2.2 kg of Lumbricus respectively, and thetemperature of sesame oil was kept at 160° C. and stirred for 40 min toafford pharmaceutical composition 4.

EXAMPLE 5

The pharmaceutical composition was prepared according to the method ofexample 1 except that the composition was consist of 10 Kg of beeswaxand 90 Kg of sesame oil extract containing 2 kg of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris andLumbricus respectively, and the temperature of sesame oil was kept at155° C. and stirred for 40 min to afford pharmaceutical composition 5.

EXAMPLE 6

The pharmaceutical composition was prepared according to the method ofexample 1 except that the composition was consist of 12 Kg of beeswaxand 88 Kg of sesame oil extract containing 1 kg of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris andLumbricus respectively, and the temperature of sesame oil was kept at160° C. and stirred for 40 min to afford pharmaceutical composition 6.

EXAMPLE 7

The pharmaceutical composition was prepared according to the method ofexample 1 except that the composition was consist of 4 Kg of beeswax and96 Kg of sesame oil extract containing 7 kg of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris andLumbricus respectively, and the temperature of sesame oil was kept at155° C. and stirred for 40 min to afford pharmaceutical composition 7.

EXAMPLE 8

Make the pharmaceutical composition in the present invention accordingto the method. The pharmaceutical composition was prepared according tothe method of example 1 except that the composition was consist of 12 Kgof beeswax and 88 Kg of sesame oil extract containing 0.5 kg of RadixScutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris and Lumbricus respectively, and the temperature of sesame oilwas kept at 155° C. and stirred for 40 min to afford pharmaceuticalcomposition 8.

EXPERIMENTAL EXAMPLE 1

Referring to FIG. 1, Deep degree III burns combined with bone burninjury were firstly treated with pharmaceutical composition 7 and 8. Inpharmaceutical composition 7 and 8, the individual weight proportion ofRadix Scutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris, and Lumbricus is 0.5% and 7% respectively of the total weightof the sesame oil extract. The necrotic tissues of deep burns wereliquefied and removed and the new granulation tissues grew out, whilethe burnt bone tissues still did not have vitality. Using thepharmaceutical composition 1 on the wounds directly and the necrotictissues on the bone membrane and bone were removed after 2 days (FIG.2).

Then drill the holes on the bone with 0.5 cm interval space and deep tothe bone marrow until the seepage of bone marrow blood and then thepharmaceutical composition 1 was used directly to cover the drilledbones and holes with the thickness of about 1-3 mm The dressing waschanged twice in every morning and night respectively (FIG. 3).

After several days, the new skin regenerated from the original bonegranulation tissues and the new granulation tissue grew out from thedrilled holes (FIG. 4 and FIG. 5). After continuous application, theskin on the granulation tissues expanded and healed the wounds and thenew granulation tissues grew out of the holes connected with each otherand regenerated new skin on the new bone granulation tissues (FIG. 6).

EXPERIMENTAL EXAMPLE 2

Referring to FIG. 2, the patient was subjected to the electrical injuryon the top of head combined with skull periosteum burnt and skullsurface necrosis. Firstly, the pharmaceutical composition 7 and 8 wereused as the control drugs for 25 days. After treatment, there was noobvious improvement of skull necrotic surface. Then the pharmaceuticalcomposition 2 obtained from example 2 was used to continue thetreatment. The treatment method was to apply the pharmaceuticalcomposition on the wounds directly with thickness of about 1-3 mm andthe dressing was changed twice in every morning and night respectivelyfor 7 days.

After 7 days treatment, remove the necrotic bone tissues from outside toinside with surgical debridement and then drill the holes on the boneswith drilling interval less than 1 cm until the bleeding of bone marrow.Then the pharmaceutical composition 2 was applied on the wounds with thethickness of about 1-3 mm and the dressing was changed twice in everymorning and night respectively (FIG. 8).

After 10 days, the granulation tissues grew out of the drilled holes andnew skin gradually regenerated and connected with each other to closethe bone wounds (FIG. 9).

After the bone wounds healed, the skin tissues can be seen (FIG. 10).The electron microscope slices shows the structures of epidermis, dermisand appendixes (except the hair follicles) (FIG. 11 and FIG. 12).

In addition, the pharmaceutical composition 1, 3-6 also have the sametherapeutic effect in the patient (data omitted).

EXPERIMENTAL EXAMPLE 3

The open fracture wound is often contaminated by the laceration, thewound infection and soft tissue non-healing is a difficult medicalproblem and the severe patient may facing amputation. This difficultmedical problem was solved effectively by the application of the presentpharmaceutical composition combined with the current surgicaldebridement and orthopedic operation. During the Wenchuan Earthquake in2008, the present pharmaceutical composition was used to treat thepatients with open fracture wounds and achieved surprising effects inthat the wound healed fast, infection was reduced, and the fracture bonegrew fast, effectively avoiding the amputation (FIG. 13).

After the accident of open fracture, the present pharmaceuticalcomposition 3 was applied on the wounds directly as early as possible.It can not only protect the wounds, isolate the wounds from the air andavoid the contamination, but also play the function of metabolizing thecontaminants and debriding the wounds without further damage. Themechanical fixation operation on the fractured bone tissue can be doneafter cleaning the wounds with normal saline. After the surgical sutureof soft tissue and skin, the pharmaceutical composition 3 was appliedagain on the sutured wounds, which can prevent the infection and promotethe wound healing. FIG. 14 shows the wound conditions after the bonefixation and suture.

After 40 days treatment, there was no infection on the wounds, thedefected skin tissue and other soft tissues were healed (FIG. 15).

In addition, the present pharmaceutical composition 4 and 5 alsoachieved the same therapeutic effect on the patients.

The inventor found that for a pharmaceutical composition with thecontents of such raw materials as Radix Scutellariae, Coptis Chinensis,Cortex Phellodendri, Pericarpium Papaveris and Lumbricus being higherthan 6% or lower than 1% by dry weight of the total weight of the sesameoil extract, it has no ideal therapeutic effect on open fracture,especially on the bone recovery. It is speculated that the highercontent (higher than 6%) of Radix Scutellariae, Coptis Chinensis, CortexPhellodendri, Pericarpium Papaveris and Lumbricus in sesame oil extractmay inhibit the cell growth on wounds; and the lower content (lower than1%) of Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris and Lumbricus in sesame oil extract does not reachthe therapeutic dosage, which cannot promote the cell growth on thewounds.

EXAMPLE 4

The severe skull electronic burn injury is also a medical problemcurrently, as there is lack of nutrition sources for the bone tissues,bone tissues are partially defected, and it is difficult to repair thebone tissues by the nutrition supply through bone marrow tissues. Thepharmaceutical composition 4 was used directly as the culture media ofbone tissues, soft tissues, and skin of the severe electrical burninjury patient combined with skull bone injury, which can directlyrepair the severe damaged bone tissues and heal the wounds.

Firstly, under the protection of the pharmaceutical composition 4, partsof the skull bone necrotic tissues were removed with the surgicaldebridement (FIG. 18) and X-ray examination shows that most of the bonetissues at the top of skull were defected and the depth of woundsreached to the endomeninx, which indicates that parts of the bone marrowtissues are defected (FIG. 19).

The pharmaceutical composition 7 and 8 were used as the control drugsfor 25 days, there was no obvious improvement at the necrotic skull bonesurface.

Then the bone tissues with partial defect were drilled and thepharmaceutical composition 4 and control drugs were continued to be usedto incubate the granulation tissues. The present pharmaceuticalcomposition 4 and control drugs were applied to cover the woundsdirectly with the thickness of about 1-3 mm and the dressing was changedtwice in every morning and night respectively.

The skull bone of patients has no improvement after using the controldrugs and then the pharmaceutical composition 4 was used to continuetreatment.

The wound conditions after using the pharmaceutical composition 4 toincubate the bone tissues and soft tissues in situ were that thesurrounding soft tissues were regenerated and the bone tissuessurrounded and in the central were growing under the effect of drug(FIG. 20). X-ray image shows that the skull bone in the middle of meninxarea was growing under the protection (FIG. 21).

After 40 days treatment, there was obvious growth of bone tissues andthe exposed area of bone membrane became smaller (FIG. 22).

The treatment was continued until the regenerative restoration in situof skull bone was realized: the exposed area of bone membrane becamesmaller and smaller, the regenerative restoration of soft tissues andskin were realized and finally the wound healed (FIG. 23).

The head skin plastic surgical operation was performed after the healingof the skull bone and wounds, and the hair of the patients can covermost of the head (FIG. 24).

Same excellent treatment effects can be achieved with the pharmaceuticalcomposition 5 and 6 in the similar tests to the above one.

EXPERIMENTAL EXAMPLE 5

Male, 29 years old patient was suffering from the severe neck, head, andfacial burn injury after carbon monoxide poisoning (FIG. 25). The bonesurface of the patient was severe necrotic and there was no granulationtissue growth after regional treatment of surgery and there was novitality of bone tissue.

The skull bone of the patient was drilled holes and then iodinetreatment was continued for 9 days followed by the application of thepharmaceutical composition 7 and 8 as control drugs for another 10 days,but there was no granulation tissue growth and viable bone tissue (FIG.26).

Then, the pharmaceutical composition 5 was used immediately withthickness of 3 mm on the wounds to cover the wounds completely. After 5days treatment, the necrotic-like bone tissues recovered vitality andthe granulation tissues grew out of the drilled holes and the vitalityof bone surface recovered and gradually formed periosteum. At this time,the wound was almost ready for skin flap grafting. The granulationtissues were incubated and maintained continuously in the vitalenvironment of bone surface until a proper time was selected for skinflap grafting to cover the entire exposed bones (FIG. 27 and FIG. 28).

The free skin flaps from the patient's back (FIG. 29 and FIG. 30) wastaken for the head skin flap grafting, and the wound of the patientrecovered gradually (FIG. 30).

What is claimed is:
 1. A method of treating open traumas complicated byfracture and/or deep thermal injury with bone injury and/orosteonecrosis comprising administration of an effective dose of apharmaceutical composition onto the affected locations, wherein saidpharmaceutical composition comprises 4%-12% of beeswax by weight basedon the total weight of said composition, and 88%-96% of sesame oilextract by weight based on the total weight of said composition, whereinthe sesame oil extract contains one or more components selected from thegroup consisting of Radix Scutellariae, Coptis Chinensis, CortexPhellodendri, Pericarpium Papaveris, and Lumbricus, and any combinationthereof, wherein each of the one or more components based on their dryweight is 1%-6% of the total weight of the sesame oil.
 2. The method ofclaim 1, wherein each of the one or more components based on their dryweight is 2%-4% of the total weight of the sesame oil.
 3. The method ofclaim 1, wherein each of the one or more components based on their dryweight is 3% of the total weight of the sesame oil.
 4. The method ofclaim 1, wherein the pharmaceutical composition comprises 4% of beeswaxby weight based on the total weight of said composition; and 96% ofsesame oil extract by weight based on the total weight of saidcomposition, wherein the sesame oil extract contains one or morecomponents selected from the group consisting of Radix Scutellariae,Coptis Chinensis, Cortex Phellodendri, Pericarpium Papaveris, andLumbricus, and any combination thereof, wherein each of the one or morecomponents based on their dry weight is 6% of the total weight of thesesame oil.
 5. The method of claim 1, wherein the pharmaceuticalcomposition comprises 6% of beeswax by weight based on the total weightof said composition; and 94% of sesame oil extract by weight based onthe total weight of said composition, wherein the sesame oil extractcontains one or more components selected from the group consisting ofRadix Scutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris, and Lumbricus, and any combination thereof, wherein each ofthe one or more components based on their dry weight is 3% of the totalweight of the sesame oil.
 6. The method of claim 1, wherein thepharmaceutical composition comprises 8% of beeswax by weight based onthe total weight of said composition; and 92% of sesame oil extract byweight based on the total weight of said composition, wherein the sesameoil extract contains one or more components selected from the groupconsisting of Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris, and Lumbricus, and any combination thereof,wherein each of the one or more components based on their dry weight is1% of the total weight of the sesame oil.
 7. The method of claim 1,wherein the pharmaceutical composition comprises 8% of beeswax by weightbased on the total weight of said composition; and 92% of sesame oilextract by weight based on the total weight of said composition, whereinthe sesame oil extract contains 5.5% Radix Scutellariae, 5.5% CoptisChinensis, 5.5% Cortex Phellodendri, 2.2% Pericarpium Papaveris, and2.2% Lumbricus, each component by weight based on the total weight ofthe sesame oil.
 8. The method of claim 1, wherein the pharmaceuticalcomposition comprises 10% of beeswax by weight based on the total weightof said composition; and 90% of sesame oil extract by weight based onthe total weight of said composition, wherein the sesame oil extractcontains one or more components selected from the group consisting ofRadix Scutellariae, Coptis Chinensis, Cortex Phellodendri, PericarpiumPapaveris, and Lumbricus, and any combination thereof, wherein each ofthe one or more components based on their dry weight is 2% of the totalweight of the sesame oil.
 9. The method of claim 1, wherein thepharmaceutical composition comprises 12% of beeswax by weight based onthe total weight of said composition; and 88% of sesame oil extract byweight based on the total weight of said composition, wherein the sesameoil extract contains one or more components selected from the groupconsisting of Radix Scutellariae, Coptis Chinensis, Cortex Phellodendri,Pericarpium Papaveris, and Lumbricus, and any combination thereof,wherein each of the one or more components based on their dry weight is1% of the total weight of the sesame oil.
 10. The method of claim 1,wherein said bone injury comprises bone injury with periosteum damage.11. The method of claim 1, wherein said administration comprisesapplying the pharmaceutical composition onto the affected locations witha thickness of about 1-3 mm.
 12. The method of claim 11, wherein saidadministration comprises applying the pharmaceutical composition ontothe affected locations with a thickness of 3 mm.
 13. The method of claim1, wherein the pharmaceutical composition is administered as a multipledose treatment.
 14. The method of claim 13, wherein the multiple dosetreatment occurs over a time period of from 7 to 40 days.
 15. The methodof claim 14, wherein the multiple dose treatment occurs over a timeperiod of 7 days.
 16. The method of claim 14, wherein the multiple dosetreatment occurs over a time period of 10 days.
 17. The method of claim14, wherein the multiple dose treatment occurs over a time period of 40days.
 18. The method of claim 1, wherein the open traumas complicated byfracture and/or deep thermal injury with bone injury and/orosteonecrosis are on a warm-blooded animal.
 19. The method of claim 1,wherein the open traumas complicated by fracture and/or deep thermalinjury with bone injury and/or osteonecrosis are on a human being. 20.The method of claim 1, wherein the bone injury is selected from shinbone injury, skull bone injury, and/or cartilage injury.